News
`Press Releases
`
`Mar 11, 2015
`
`Print
`
`Mylan Launches Generic Subutex® Sublingual
`Tablets
`
`POTTERS BAR, England and PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ MYL)
`and Mylan Inc. today announced the U.S. launch of Buprenorphine Hydrochloride Sublingual Tablets, 2 mg
`and 8 mg, which is the generic version of Reckitt Benckiser's Subutex® Sublingual Tablets. Mylan received
`final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application
`(ANDA) for this product, which is indicated for the treatment of opioid dependence and is preferred for
`induction,
`
`Buprenorphine Hydrochloride Sublingual Tablets, 2mg and 8mg had U.S. sales of approximately $107.8
`million for the 12 months ending December 31, 2014, according to IMS Health.
`
`Currently, Mylan has 281 ANDAs pending FDA approval representing $104.6 billion in annual brand sales,
`according to IMS Health, Forty -four of these pending ANDAs are potential first -to -file opportunities,
`representing $27.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS
`Health.
`
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy
`unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the
`future through passionate global leadership. We offer a growing portfolio of around 1,400 generic
`pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies,
`upon which approximately 40% of HIV /AIDS patients in developing countries depend. We also operate one of
`the largest active pharmaceutical ingredient manufacturers and currently market products in about 145
`countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health
`for a better world, one person at a time. Learn more at mylan.com.
`
`To view the original version on PR Newswire, visit:http: / /wmv.prnewswire .cam /news -releases /mylan-
`1 aunche s -g e ne ric -su butez- sublingual- tablets -300048812. htm l
`
`SOURCE Mylan N.V.
`
`Investor
`Products
`
`NCI Exhibit 2010
`Page 1 of 6
`
`NCI Exhibit 2043
`
`

`
`5/18/2015
`Company
`
`Mylan Launches Generic Subutex6D Sublingual Tablets
`
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`NCI Exhibit 2010
`Page 2 of 6
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`7/142015
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`Mylan Lauches Generic Mtabuse® Tablets Mar 11, 2018
`
`News
`i Select
`
`vl
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`Mylan Launches Generic Antabuse® Tablets
`
`Print
`
`POTTERS BAR, England and PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ:
`MYL) and Mylan Inc. today announced the U.S. launch of Disulfiram Tablets USP, 250 mg and 500 mg,
`which is the generic version of Odyssey Pharmaceutical's Antabusem. Mylan received final approval from
`the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this
`product, which is an aid In the management of selected chronic alcohol patients who want to remain In a
`state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to the
`best advantage.(1)
`Disulfiram Tablets USP, 250 mg and 500 mg, had U.S. sales of approximately $16.4 million for the 12
`months ending December 31, 2014, according to IMS Health.
`Currently, Mylan has 282 ANDAs pending FDA approval representing $104.7 billion in annual brand
`sales, according to IMS Health. Forty -four of these pending ANDAS are potential first -to -file
`opportunities, representing $27.3 billion in annual brand sales, for the 12 months ending June 30, 2014,
`according to IMS Health.
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to
`satisfy unmet needs; make reliability and service excellence a habit: do what's right, not what's easy;
`and impact the future through passionate global leadership. We offer a growing portfolio of around
`1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of
`antireiroviral therapies, upon which approximately 40% of HIV /AIDS patients in developing countries
`depend. We also operate one of the largest active pharmaceutical Ingredient manufacturers and
`currently market products in about 145 countries and territories. Our workforce of approximately 30,000
`people is dedicated to creating better health for a better world, one person at a time. Learn more at
`mylan.com.
`
`(1) Disulfiram should never be administered to a patient when he is in a state of alcohol intoxication, or
`without his full knowledge. Disulfiram plus alcohol, even small amounts, produce flushing, throbbing in
`head and neck, throbbing headache, respiratory difficulty, nausea, copious vomiting, sweating, thirst,
`chest pain, palpitation, dyspnea, hyperventilation, tachycardia, hypotension, syncope, marked
`uneasiness, weakness, vertigo, blurred vision, and confusion. In severe reactions there may be
`respiratory depression, cardiovascular collapse, arrhythmias, myocardial infarction, acute congestive
`heart failure, unconsciousness, convulsions, and death.
`To view the original version an PR Newswire, visit: http: / /www.prnewswire.com /nows- releases /mylan-
`launches- generic -antabuse- tablets- 300048510.html
`
`Nlrrfircwsroom.m yl aracan /I nrkx, pI p7s= 24208f tem- 12328a
`
`NCI Exhibit 2010
`Page 3 of 6
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`12
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`
`7/14/2015
`SOURCE Mylan N.V.
`
`Mylan Launches Generic Anlabuse® Tablets Mar 11, 2015
`
`For further information: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813
`
`hripl/newsra>tn.mylan.caNlnclez.PhP7s=2420811emm123233
`
`NCI Exhibit 2010
`Page 4 of 6
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`7/1472015
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`Mylan[mux:twsFüstaodOrlyAveilaMehrtermediateDcsegeStrengthsotFerNartytTretedetmet9ystem37.5,525ard07.5mcgdx-Mar11,2015
`
`News
`! Select
`
`Mylan Launches First and Only Available
`Intermediate Dosage Strengths of Fentanyl
`Transdermal System 37.5, 62.5 and 87.5 mcg /hr
`
`Print
`
`POTTERS BAR, England and PITTSBURGH, March 11, 2015 /PRNewswire/ Mylan N.V. (Nasdaq:
`MYL) and Mylan Inc. today announced the U.S. launch of its Fentanyl Transdermal System 37.5, 62.5
`and 87.5 mcg /hr, adding to Its existing offering of Fentanyl Transdermal System 12, 25, 50, 75 and 100
`mcg /hr. Mylan currently is the only manufacturer that offers eight Fentanyl Transdermal System dosage
`strengths, including three new strengths - the first and only available "intermediate" dosages.
`Mylan CEO Heather Bresch commented: " Mylan's launch of Fentanyl Transdermal System 37.5, 62.5
`and 87.5 mcg/hr, is an example of our commitment to innovate to satisfy unmet needs. Mylan's Fentanyl
`Transdermal System Is the number one dispensed fentanyl transdermal system in the U.S.i, and now,
`for the first time, patients have access to additional dosing options through Mylan's launch of three new
`strengths."
`
`Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Supplemental
`Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System 37.5, 62.5 and 87.5
`mcg /hr.
`Fentanyl Transdermal System's existing strengths, including the 12, 25, 50, 75 and 100 mcg /hr
`presentations, had U.S. sales of approximately $767 million for the 12 months ending September 30,
`2014, according to IMS Health.
`Currently, Mylan has 282 ANDAS pending FDA approval representing $104.6 billion in annual brand
`sales, according to IMS Health. Forty -three of these pending ANDAS are potential first -to -file
`opportunities, representing $27.2 billion in annual brand sales, for the 12 months ending June 30, 2014,
`according to IMS Health.
`
`Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working
`together around the world to provide 7 billion people access to high quality medicine, we innovate to
`satisfy unmet needs: make reliability and service excellence a habit; do what's right, not what's easy;
`and impact the future through passionate global leadership. We offer a growing portfolio of around
`1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of
`antiretroviral therapies, upon which approximately 40% of HIV /AIDS patients in developing countries
`depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and
`currently market products in about 145 countries and territories, Our workforce of approximately 30,000
`people is dedicated to creating better health for a better world, one person at a time. Learn more at
`NCI Exhibit 2010
`Page 5 of 6
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`Mylan Launches Float and Only AveMahle Intermediate Dosage Strengths of Fenlanyl Trasdermal System 375, 62.5 and 87.5 mcgrtr Mar 11, 2015
`7/14/2015
`mylan.com.
`
`1
`
`VMS Health, NPA^", Dispensed Moving Annual Total (MAT) Prescriptions, December 2013 through
`November 2014.
`
`To view the original version on PR Newswire, visit:http://www.prnowswire.com/nows-releases/myian-
`l a u n c h e s-fi rst-a n d-on i y-av a i l a b l e-lntermed iate-dosa g e-stren g t h s-of-fen t a n y l-t ran s d ermal-
`system-375-825-and-875-mcghr-300048809.html
`
`SOURCE Mylan N.V.
`
`For further information: Nina Devlin (Media), 724.514.1968 or Kris King (Investors), 724.514.1813
`
`l6tpl/newsroom.mylan.carnhrder.ptV7s=242081tem=123287
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`Page 6 of 6
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